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A Brief Overview of Pilot Studies and Their Sample Size Justification

Overview
Journal Fertil Steril
Date 2024 Feb 8
PMID 38331310
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Abstract

Pilot studies, when properly designed and implemented, are an important tool that provide critical information for the development and potential success of a subsequent, larger trial. In fact, these small-scale studies are commonly used to assess the feasibility of whether a larger trial should be initiated. A popular investigator question is whether a pilot study requires a formal statistical power calculation. In general, the answer is "no"; however, the sample size needs to be justified on the basis of the goal of the pilot study.

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